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NCT05064020 · ClinicalTrials.gov registry record
Bictegravir in the Elderly Living With HIV (BICEP)
A clinical trial of HIV-1-infection, sponsored by State University of New York at Buffalo.
- Active
- Registry status
- 162
- Enrollment target
- 1
- Study location
NCT05064020: Active study of HIV-1-infection, sponsored by State University of New York at Buffalo.
NCT05064020 is a study of HIV-1-infection that is active but no longer recruiting, run by State University of New York at Buffalo. The registered enrollment target is 162 participants, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05064020, a study of HIV-1-infection, is active but no longer recruiting, sponsored by State University of New York at Buffalo.
- ACTIVE NOT RECRUITING
- Registry status
- 162 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, open-label, single center, post-approval and post-marketing study. Current national guideline recommends an integrase strand inhibitors (INSTI) in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) as standard of therapy for HIV-1 infected patients. INSTI-based regimen may require a potent CYP3A inhibitor such as cobicistat to increase INSTI's plasma concentration and prolongs half-life. However, co-administration with a CYP3A inhibitor may increase the risk of drug-drug interactions. A novel INSTI, bictegravir, does not need a booster for pharmacokinetic enhancement. Hypothesis: switching HIV-1 infected patients from booster containing regimen to bictegravir based regimen would decrease the risk of drug-drug interactions caused by a booster and improve quality of life and adherence.
Conditions Studied
Interventions
- DRUG Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]
Study Locations (1)
New York
- Evergreen Health - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2024-12-31 |
What the registry record for NCT05064020 still lists
NCT05064020 is an observational study that tracks outcomes without assigning an intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (54% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY] is the first listed.
NCT05064020 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05064020 about?
NCT05064020 is a clinical study titled "Bictegravir in the Elderly Living With HIV (BICEP)". This is a prospective, open-label, single center, post-approval and post-marketing study. Current national guideline recommends an integrase strand inhibitors (INSTI) in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) as standard of therapy for HIV-1 infected patients. INSTI...
What is the current status of trial NCT05064020?
This trial is currently active not recruiting. The enrollment target is 162 participants. The study started on 2020-08-01. Estimated completion is 2024-12-31.
What conditions does trial NCT05064020 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT05064020?
The interventions under investigation include: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY] (DRUG).
Who is sponsoring clinical trial NCT05064020?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05064020 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05064020's enrollment target sits among peer trials
162 21st of 71 higher than 51 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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